Residual Solvents Test
Residual solvents in drugs are trace volatile organic compounds used in drug production, which will remain in the finished product. Residual solvents may also come from the packaging in contact. The presence of residual solvents must be closely monitored and limited, because even at trace levels, these solvents can affect the safety and effectiveness of drugs. Therefore, testing residual solvents is a necessary part of the pharmaceutical production process to ensure the quality of the final product.
CD Formulation laboratory is cGMP-compliant and equipped with state of the art analytical instruments. We have experienced analysis experts who can work with our formulation and manufacturing team to provide you with residual solvents test services. Our residual solvents test is performed in accordance with pharmacopeia methods, in particular ICH guideline Q3C (R5), USP <467> and Ph. Eur. 5.4. The accurate and robust data generated for residual solvents, which can help you to make an appropriate risk assessment for your finished drug products. In addition, we are also able to develop and validate tailored methods of residual solvents test that will meet your specific needs.
In ICH Q3C, the permitted daily exposure (PDE) is based on the toxicity of the solvent. Solvents are defined into three class:
- Class 1 solvents: Solvents to be avoided—known human carcinogens, strongly suspected human carcinogens, and environmental hazards.
- Class 2 solvents: Solvents to be limited—on-genotoxic animal carcinogens or possible causative agents of other irreversible toxicity such as neurotoxicity or teratogenicity. Solvents suspected of other significant but reversible toxicities.
- Class 3 solvents: Solvents with low toxic potential—solvents with low toxic potential to man; no health-based exposure limit is needed. Class 3 solvents have PDEs of 50 mg or more per day.
The Requirement of Residual Solvent Test
| What is the sample? Excipient/Drug Substance/Drug Product? |
| Is sample water-soluble or water-insoluble? If unknown, we may require additional testing to determine solubility. |
| List any known residual solvents expected, including any Class 1, 2 or 3 as well as ethylene oxide or any other residual solvents. |
| The default approach for Class 1 and 2 solvents is a limit test. Indicate if you require a quantified result, this may require verification testing under the protocol. |
| Sample > 6 grams, a minimum of 1 gram of sample be provided for testing, Verification testing will require an additional 5 grams of material. |
Our Methods of Residual Solvents Test
- Headspace Gas Chromatography or Gas Chromatography - Mass Spectrometry (GC-MS)
- Gravimetric Techniques
- Method development to ICH guidelines
Deliverable
- Data analysis
- Provide full study report
Our Advantages
If you have a requirement about residual solvents test services, please contact us by phone or email, our colleagues will reply to you within three working days.
References
- Guideline I C H H T. Impurities: Guideline for Residual Solvents Q3C (R5) [J]. Current Step, 2005, 4: 1-25.
- Grodowska K, Parczewski A. Analytical Methods for Residual Solvents Determination in Pharmaceutical Products[J]. Acta Pol. Pharm, 2010, 67(1): 13-26.
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